Immunogenicity of quadrivalence recombinant human papillomavirus vaccine (6, 11, 16 and 18 types) (<italic>Hansenulapolymorpha</italic>): results from phaseⅠ clinical trial

Yun Kang; Qiang LU; Ge QU; Jing Zhang; Chenyan Zhao; Lifang DU; Junkai Liu; Qiang Liu; Jianhui Nie; Yunhua Bai; Fengji Luo; Qiming LI

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Immunogenicity of quadrivalence recombinant human papillomavirus vaccine (6, 11, 16 and 18 types) (Hansenulapolymorpha): results from phaseⅠ clinical trial

VernacularTitle: 四价重组人乳头瘤病毒疫苗(6/11/16/18型)(汉逊酵母)Ⅰ期临床研究中的免疫原性观察
Author: Yun KANG ¹ ; Qiang LU ² ; Ge QU ³ ; Jing ZHANG ¹ ; Chenyan ZHAO ⁴ ; Lifang DU ¹ ; Junkai LIU ⁴ ; Qiang LIU ⁴ ; Jianhui NIE ⁴ ; Yunhua BAI ² ; Fengji LUO ² ; Qiming LI ¹
Author Information

1. National Vaccine & Serum Institute, Beijing 101111, China
2. Department of Biological Products, Beijing Chaoyang District Center for Diseases Prevention and Control, Beijing 100021, China
3. Chengdu Institute of Biological Products Co., Ltd., Chengdu 610023, China
4. Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing 100050, China
Publication Type:Journal Article
Keywords: Quadrivalence recombinant human papillomavirus vaccine (6, 11, 16 and 18 types) (Hansenulapolymorpha); Immunogenicity; Seroconversion rate; Geometric mean titer
From:Chinese Journal of Microbiology and Immunology 2019;39(12):916-920
CountryChina
Language:Chinese
Abstract: Objective:To make a preliminary assessment on the immunogenicity of a quadrivalence recombinant human papillomavirus (HPV) vaccine (6, 11, 16 and 18 types) (Hansenulapolymorpha) in healthy women aged 18-45 years in phaseⅠclinical study.
Methods:It was a single-center, double-blind, randomized, placebo-controlled phaseⅠ clinical study. Women aged 18-45 years were randomized (2∶1) to receive HPV vaccine (n=60) or placebo control (n=30) at months 0, 2 and 6. Antibodies against HPV6/11/16/18 were detected by pseudovirus-based neutralisation assay in serum samples collected at 0 d, 180 d and 210 d. Seroconversion rates and geometric mean titres (GMT) of antibodies against the four types of antigens were calculated.
Results:Seroconversion rates of the vaccination group at 180 d (before the third dose) and 210 d (one month after the third dose) were generally similar and between 85%-100% for all types of antibodies. The GMT of antibodies at one month after the last dose improved significantly compared with those before immunization.
Conclusions:These results showed that the HPV vaccine had good immunogenicity in the population of healthy women aged 18-45 years. Higher antibody titers were elicited by the vaccine compare with the tites before the first dose and in the placebo control group.